- Home
- Case studies
- Medical device cybersecurity fda compliance
Securing Medical Devices: Cybersecurity and FDA Compliance Achieved
A trusted developer of connected medical devices partnered with Lynx to streamline cybersecurity compliance and maintain product security throughout their lifecycle. By leveraging Lynx’s expertise in BSP lifecycle maintenance and vulnerability management, the manufacturer ensured FDA compliance while freeing resources for next-generation innovations.

Overview
A trusted developer of connected medical devices needed a secure and compliant way to manage their product portfolio. Facing mounting pressures to maintain cybersecurity, comply with FDA regulations, and address healthcare customer requirements, the company partnered with Lynx for a transformative solution. Through tailored infrastructure and automated vulnerability management, Lynx empowered the manufacturer to maintain security while optimizing their engineering resources.
About the Client
This case study highlights a trusted global manufacturer specializing in advanced connected medical devices. Their product line features NXP i.MX 6 series processors and an Advantech Yocto Linux BSP. Operating in a highly regulated industry, the client’s top priorities included meeting federal quality system regulations, addressing healthcare information security requirements, and ensuring patient safety.
Challenge
Meeting High-Stakes Medical Device Security Needs
Maintaining product security and compliance posed significant challenges:
- Complex Vulnerability Management: The engineering team relied on a manual process to track vulnerabilities, assess their impact, and apply fixes—diverting resources from innovation.
- Regulatory Pressures: Compliance with FDA cybersecurity guidance required consistent monitoring and mitigation of risks across the entire lifecycle.
- High Customer Standards: Healthcare providers demanded strict security assurances, further complicating the manufacturer’s operational requirements.
The stakes were high: a single vulnerability could jeopardize patient safety, regulatory approvals, and customer trust.
Solution
A Unified Platform for Cybersecurity and Compliance
Lynx designed a comprehensive, collaborative infrastructure to address the manufacturer’s challenges, ensuring security and compliance across their product lifecycle:
- Automated Build and Test Frameworks: Established a shared Git repository with repeatable builds, automated testing, and robust version control to ensure consistent updates.
Benefit: Simplified updates, reduced manual errors, and ensured security across all devices. - Vigiles® Vulnerability Management Suite: Delivered real-time CVE monitoring, prioritized patches, and actionable reporting, significantly reducing the time required for vulnerability assessments.
- Benefit: Faster responses to threats, fewer false positives, and a stronger security posture.
- BSP Maintenance Cadence: Introduced a systematic update schedule with monthly security reviews and tailored recommendations.
- Benefit: Predictable updates streamlined compliance with FDA guidance while reducing operational friction.
This unified solution enabled the manufacturer to meet their security and compliance goals while redirecting their focus toward next-generation device development.
Results
Building Confidence and Driving Innovation
The partnership with Lynx delivered measurable success and long-term benefits:
- Regulatory Confidence: Streamlined adherence to FDA cybersecurity guidance, ensuring devices met stringent federal and healthcare industry standards.
- Resource Optimization: Freed internal engineering teams to focus on state-of-the-art product development rather than manual security updates.
- Lifecycle Protection: Maintained a robust security posture throughout the product lifecycle, mitigating risks for patients and customers alike.
- Operational Efficiency: Reduced time and effort spent on vulnerability management with automated tools and actionable reporting.
Through this collaboration, Lynx enabled the manufacturer to secure their portfolio, meet compliance standards, and focus on the future of medical innovation.
Secure Your Medical Devices with Lynx
Your mission-critical devices deserve the best in cybersecurity and compliance. Partner with Lynx to streamline FDA compliance, maintain product security, and unlock resources for innovation.